AV-001 for Hemodialysis

Overseen By Kathy Koyle

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: London Health Sciences Centre Research Institute

Disqualifiers: Severe cognitive impairment, Previous stroke, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new medication, AV-001, can protect the brain from potential injury during hemodialysis, a treatment for kidney failure. People on regular dialysis sometimes experience cognitive decline, such as memory issues or mental fog, which this medication aims to reduce by strengthening brain blood vessels and reducing inflammation. The trial includes three groups: one receiving a placebo, another a low dose of AV-001, and the last a higher dose, all administered before dialysis sessions. It suits those who have been on dialysis three times a week for at least three months and have not experienced severe memory issues or strokes in the past. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that AV-001 is likely to be safe for humans?

Research has shown that AV-001 has undergone safety testing in people before. In earlier studies, most patients who received multiple doses of AV-001 generally tolerated it well, with few serious side effects. Most experienced only mild reactions, such as headaches or slight nausea.

This study remains in the early stages, so more information about the treatment's safety is needed. However, the previous testing of AV-001 without major issues is promising, suggesting that the treatment could be safe for most people. Individual experiences may vary, so discussing any concerns with the study team is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cognitive decline?

Researchers are excited about AV-001 for hemodialysis because it offers a potential new way to improve patient outcomes. Unlike standard treatments that manage symptoms, AV-001 is designed to enhance the body's response to hemodialysis. It comes in two doses: a low dose (12.5μg/kg) and a high dose (25μg/kg), administered shortly before dialysis sessions, which could optimize the treatment's efficacy. This approach may lead to improved efficiency in dialysis treatments and better overall health for patients undergoing this life-sustaining procedure.

What evidence suggests that AV-001 might be an effective treatment for cognitive decline in hemodialysis patients?

Research has shown that AV-001 might protect the brain from damage caused by hemodialysis. It strengthens blood vessels in the brain and reduces swelling. Studies have found that AV-001 can improve brain health and assist with memory and thinking problems. Early results suggest it might also prevent brain swelling and maintain brain function. In this trial, participants will be randomized into groups to receive either a placebo, a low dose of AV-001, or a high dose of AV-001. This treatment could be promising for individuals experiencing memory and thinking issues during regular dialysis sessions. ^{1 3 6 7 8}

Who Is on the Research Team?

Christopher W McIntyre, MD/PhD

Principal Investigator

London Health Science Centre

Are You a Good Fit for This Trial?

This trial is for individuals on maintenance hemodialysis who may be experiencing cognitive issues like memory problems or slower thinking. Participants must meet certain health criteria to join, but specific inclusion and exclusion details are not provided.

Inclusion Criteria

I have been on hemodialysis for 3 months or more.

I am on a thrice weekly hemodialysis schedule.

Ability to provide informed consent

Exclusion Criteria

Contraindication to MRI

Established severe cognitive impairment (Montreal Cognitive Assessment test (MoCA) <18 or formal diagnosis of dementia)

I have been on hemodialysis for less than 90 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AV-001 (low or high dose) or placebo 60 minutes prior to HD initiation at 3 HD treatment sessions within 1 week

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AV-001

Trial Overview The study tests AV-001, a new medication aimed at protecting the brain from dialysis-related injury by strengthening brain blood vessels and reducing inflammation, compared to a placebo injection.

How Is the Trial Designed?

Group I: Group 3: AV-001 High Dose (25μg/kg) Experimental Treatment 1 Intervention

Participants randomized into group 3 will receive AV-001 high dose. AV-001 high dose will be administered 60 minutes prior to hemodialysis initiation, 3 x over a one-week treatment period.

Group II: Group 2: AV-001 low dose (12.5μg/kg) Experimental Treatment 1 Intervention

Participants randomized into group 2 will receive AV-001 low dose. AV-001 low dose will be administered 60 minutes prior to hemodialysis initiation, 3 x over a one-week treatment period.

Group III: Group 1 Placebo Experimental Treatment 1 Intervention

Participants randomized into one group 1placebo. Placebo will be administered 60 minutes prior to hemodialysis initiation, 3 x over a one-week treatment period.

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07234890

Study to Evaluate the Effects of AV-001 on HD-induced ... Significant cognitive impairment is evident within 6 months of starting HD. This study is a phase 2 exploratory study in patients receiving ...

2. biospace.com biospace.com/press-releases/health-canada-gives-green-light-to-new-study-investigating-novel-made-in-canada-drug-candidate-to-prevent-brain-injury-in-hemodialysis-patients

Health Canada Gives Green Light to New Study ... Published data using Pegevongitide (AV-001) demonstrated that this mechanism can improve neurological health, reduce cognitive impairment ...

3. anges.co.jp anges.co.jp/pdf_news/public/NPeGO6y29qOriTBrOMpDRAypAcMLOsJJ.pdf

Notice Regarding the Initiation of a New Clinical Study for ... This study aims to evaluate whether AV-001 can mitigate cytotoxic cerebral edema caused by hemodialysis and help preserve white matter function in the brain ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05123755

NCT05123755 | Phase 2a Multiple Ascending Dose Study ... Efficacy of multiple IV administrations of AV-001 Injection compared with AV-001 placebo Injection in patients hospitalized with pneumonia due to COVID-19 and/ ...

5. jvascsurg.org jvascsurg.org/article/S0741-5214(25)00678-0/fulltext

Predicting 1-year Successful Clinical Use of an ... The primary outcome was 1-year successful clinical use of the index AV access for hemodialysis. The data were divided into training (70%) and test (30%) sets.

6. firstwordpharma.com firstwordpharma.com/story/5994445

Health Canada Gives Green Light to New Study Investigating ... Published data using Pegevongitide (AV-001) demonstrated that this mechanism can improve neurological health, reduce cognitive impairment, and reduce ...

7. ichgcp.net ichgcp.net/amp/clinical-trials-registry/NCT07234890

Study to Evaluate the Effects of AV-001 on HD-induced ... - ICH GCP This research is being done to determine if a new medication (AV-001) can protect the brain from injury caused by hemodialysis by strengthening blood vessels in ...

8. marketwatch.com marketwatch.com/press-release/health-canada-gives-green-light-to-new-study-investigating-novel-made-in-canada-drug-candidate-to-prevent-brain-injury-in-hemodialysis-patients-a9b0af2e?gaa_at=eafs&gaa_n=AWEtsqel_tpn9wlW_Ewd6AdpPagJkScjL1gjaak8NVvW7kObzDmLAOdc23QI&gaa_ts=69205209&gaa_sig=nxgauCPgWeiuCwtptPTO35g1V-PWxgrtfQYytl5pBOV4YeOH6zJpZPg3ND6Hn2-F9V2QNwRzC2XJdoVE0xyCWw%3D%3D

Health Canada Gives Green Light to New Study Investigating ... The study will assess whether Pegevongitide (AV-001) can reduce hemodialysis-induced cytotoxic brain edema and preserve white matter integrity. Advanced ...